Efficacy of a Transparent Silicone Membrane With Physical Microstructure for Second-degree Burn Wounds and Skin Graft Wounds
NCT ID: NCT06170008
Last Updated: 2023-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2023-12-30
2026-12-30
Brief Summary
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The development of a new type of wound dressing is urgently needed because existing wound dressings cannot be transparent, easy to change, easy to store and inexpensive at the same time.
Participants will receive routine wound treatment, after which they will be covered with a clear silicone membrane with physical microstructure modification.
Researchers will compare vaseline gauze group and decellularised pigskin group o see if transparent silicone film with physical microstructure modifications promotes wound healing, reduces the number of dressing changes, reduces the damage to the wound and painful irritation to the patient during dressing changes, thus improving the quality of wound repair and saving medical costs.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
After skin grafting, the wounds were covered with transparent silicone film and petroleum jelly gauze with physical microstructure modification.
TREATMENT
NONE
Study Groups
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Second-degree burn wounds covered with silicone film sheet group
After routine clinical treatment of second-degree burn wounds, the innermost layer is covered with physical microstructure-modified transparent silicone film sheet , and the outer dressing is changed every 3 to 4 days to observe and record the wounds, and the innermost dressing is changed weekly or as necessary and the number of times is recorded to observe the wound healing rate, dressing transparency, dressing-wound adhesion, pain level, wound infection rate and incidence of adverse reactions.
Physical microstructure-modified transparent silicone film sheet
The main component of the physical microstructure-modified transparent silicone film sheet is transparent silicone rubber, which has a three-dimensional microstructure on its trauma contact surface through physical mechanics treatment, which can provide effective mechanical stimulation for trauma healing. And after testing, the silicone film sheet is breathable, light-permeable, non-toxic and non-allergenic. It is expected to significantly reduce the number of dressing changes, reduce the damage to the wound and the painful stimulation to the patient during dressing changes, and promote the healing of the wound to a certain extent, thus improving the quality of wound repair and saving medical costs.
Second-degree burn wounds covered with decellularized pig skin group
After routine clinical treatment of second-degree burn wounds, the innermost layer was covered with decellularized pig skin, the outer dressing was changed every 3 to 4 days, the wounds were observed and recorded, and the innermost dressing was changed weekly or as necessary and the number of times was recorded to observe the wound healing rate, dressing transparency, dressing-wound adhesion, pain level, wound infection rate and incidence of adverse reactions.
Decellularized pig skin
Decellularized pig skin is an allogeneic trauma covering from pigs and is a commonly used trauma covering for second-degree burn wounds. It adheres to clean superficial wounds, creates a temporary barrier to the wound, reduces wound exudation, limits loss of body components, improves microcirculatory stasis, provides a microenvironment suitable for wound healing, protects inter-ecological tissue, promotes repair and regeneration, and reduces pain. Its disadvantages are: soft structure, difficult to fix the trauma; opaque, unable to observe the trauma; pigskin needs to be stored under suitable temperature and humidity, and has a limited time. When used, decellularized pig skin is directly covered on conventionally treated second-degree burn wounds.
Post-operative skin grafting wounds covered with silicone film sheet group
After skin grafting, the innermost layer is covered with physical microstructure-modified transparent silicone film sheet , and the outer dressing is changed every 3 to 4 days to observe and record the wound. The innermost layer is changed weekly or as necessary and the number of times is recorded to observe the wound healing rate, transparency of the dressing, adhesion of the dressing to the wound, pain, wound infection rate and incidence of adverse reactions.
Physical microstructure-modified transparent silicone film sheet
The main component of the physical microstructure-modified transparent silicone film sheet is transparent silicone rubber, which has a three-dimensional microstructure on its trauma contact surface through physical mechanics treatment, which can provide effective mechanical stimulation for trauma healing. And after testing, the silicone film sheet is breathable, light-permeable, non-toxic and non-allergenic. It is expected to significantly reduce the number of dressing changes, reduce the damage to the wound and the painful stimulation to the patient during dressing changes, and promote the healing of the wound to a certain extent, thus improving the quality of wound repair and saving medical costs.
Post-operative skin grafting wounds covered with vaseline gauze group
After skin grafting, the innermost layer was covered with vaseline gauze, and the outer layer was changed every 3 to 4 days to observe and record the wound. The innermost layer was changed weekly or as necessary and the number of times was recorded to observe the wound healing rate, transparency of the dressing, adhesion of the dressing to the wound, pain, wound infection rate and incidence of adverse reactions.
Vaseline gauze
Vaseline gauze is the most commonly used conventional dressing for the implant area, which is mainly made of skimmed cotton gauze impregnated with petroleum jelly and paraffin oil, which has a lubricating effect and can promote the growth of granulation and wound healing. However, its moisturizing time is relatively short and requires frequent dressing changes; moreover, petroleum jelly gauze often adheres to the wound surface severely, which may cause bleeding and new epidermal damage during dressing changes and affect the wound healing; the wound surface is constantly oozing blood and fluid, and the dressing cannot be effectively isolated from the outside world after wetting, which increases the chance of infection. Vaseline gauze is applied directly to the post-operative skin grafting wound.
Interventions
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Physical microstructure-modified transparent silicone film sheet
The main component of the physical microstructure-modified transparent silicone film sheet is transparent silicone rubber, which has a three-dimensional microstructure on its trauma contact surface through physical mechanics treatment, which can provide effective mechanical stimulation for trauma healing. And after testing, the silicone film sheet is breathable, light-permeable, non-toxic and non-allergenic. It is expected to significantly reduce the number of dressing changes, reduce the damage to the wound and the painful stimulation to the patient during dressing changes, and promote the healing of the wound to a certain extent, thus improving the quality of wound repair and saving medical costs.
Decellularized pig skin
Decellularized pig skin is an allogeneic trauma covering from pigs and is a commonly used trauma covering for second-degree burn wounds. It adheres to clean superficial wounds, creates a temporary barrier to the wound, reduces wound exudation, limits loss of body components, improves microcirculatory stasis, provides a microenvironment suitable for wound healing, protects inter-ecological tissue, promotes repair and regeneration, and reduces pain. Its disadvantages are: soft structure, difficult to fix the trauma; opaque, unable to observe the trauma; pigskin needs to be stored under suitable temperature and humidity, and has a limited time. When used, decellularized pig skin is directly covered on conventionally treated second-degree burn wounds.
Vaseline gauze
Vaseline gauze is the most commonly used conventional dressing for the implant area, which is mainly made of skimmed cotton gauze impregnated with petroleum jelly and paraffin oil, which has a lubricating effect and can promote the growth of granulation and wound healing. However, its moisturizing time is relatively short and requires frequent dressing changes; moreover, petroleum jelly gauze often adheres to the wound surface severely, which may cause bleeding and new epidermal damage during dressing changes and affect the wound healing; the wound surface is constantly oozing blood and fluid, and the dressing cannot be effectively isolated from the outside world after wetting, which increases the chance of infection. Vaseline gauze is applied directly to the post-operative skin grafting wound.
Eligibility Criteria
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Inclusion Criteria
* Second-degree burns with an area greater than 1% TBSA and a single observable trauma area ≥ 10 cm × 10 cm(jointly determined by two burn specialists with the title of attending physician or above according to the four degrees and five points method);
* Voluntary signed informed consent form
Exclusion Criteria
* Significant cardiac, pulmonary and renal insufficiency;
* Critically ill or with serious complications such as severe sepsis or MODS;
* Positive for HBV, HCV, HIV or syphilis;
* Traumatic surface infection;
* Involving the face, hands, groin, joints, feet and other areas difficult to bandage and fix; previous burn trauma treatment; previous burns on the same site; electrical burns; patients with inhalation injuries.
* Known sensitivity or allergy to one of the dressings or its components; diabetes mellitus; presence of immune system disorders or long-term hormone or immunotherapy
* Others who, in the opinion of the investigator, are not suitable for enrollment.
12 Years
70 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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chhaodylan
Identifier Type: -
Identifier Source: org_study_id